Clinical Policy: Deutetrabenazine (Austedo) Reference Number: ERX.SPA.150 Effective Date:

Transcription

1 Clinical Plicy: (Austed) Reference Number: ERX.SPA.150 Effective Date: Last Review Date: Revisin Lg See Imprtant Reminder at the end f this plicy fr imprtant regulatry and legal infrmatin. Descriptin (Austed ) is a vesicular mnamine transprter 2 (VMAT2) inhibitr. FDA Apprved Indicatin(s) Austed is indicated fr the treatment f: Chrea assciated with Huntingtn s disease Tardive dyskinesia in adults Plicy/Criteria Prvider must submit dcumentatin (such as ffice chart ntes, lab results r ther clinical infrmatin) supprting that member has met all apprval criteria. It is the plicy f health plans affiliated with Envlve Pharmacy Slutins that Austed is medically necessary when the fllwing criteria are met: I. Initial Apprval Criteria A. Huntingtn s Disease (must meet all): 1. Diagnsis f chrea assciated with Huntingtn s disease; 2. Prescribed by r in cnsultatin with a neurlgist; 3. Age 18 years; 4. Failure f tetrabenazine at up t 100 mg/day, unless cntraindicated r clinically significant adverse effects are experienced; 5. Austed is nt prescribed cncurrently with tetrabenazine r valbenazine; 6. Dse des nt exceed 48 mg/day. Apprval duratin: 6 mnths B. Tardive Dyskinesia (must meet all): 1. Diagnsis f tardive dyskinesia secndary t a centrally acting dpamine receptr blcking agent (DRBA); *See Appendix E; if the ffending agent is nt included in Appendix D, the status f the agent as a centrally acting DRBA as well as its assciatin with tardive dyskinesia shuld be cnfirmed 2. Prescribed by r in cnsultatin with a psychiatrist r neurlgist; 3. Age 18 years; 4. Austed is nt prescribed cncurrently with tetrabenazine r valbenazine; 5. Dse des nt exceed 48 mg/day. Apprval duratin: 6 mnths B. Other diagnses/indicatins 1. Refer t ERX.PA.01 if diagnsis is NOT specifically listed under sectin III (Diagnses/Indicatins fr which cverage is NOT authrized). II. Cntinued Therapy A. All Indicatins in Sectin I (must meet all): 1. Currently receiving medicatin via a health plan affiliated with Envlve Pharmacy Slutins r member has previusly met initial apprval criteria; 2. Member is respnding psitively t therapy; 3. Austed is nt prescribed cncurrently with tetrabenazine r valbenazine; 4. If request is fr a dse increase, new dse des nt exceed 48 mg/day. Apprval duratin: 12 mnths Page 1 f 5

2 B. Other diagnses/indicatins (must meet 1 r 2): 1. Currently receiving medicatin via a health plan affiliated with Envlve Pharmacy Slutins and dcumentatin supprts psitive respnse t therapy. Apprval duratin: Duratin f request r 6 mnths (whichever is less); r 2. Refer t ERX.PA.01 if diagnsis is NOT specifically listed under sectin III (Diagnses/Indicatins fr which cverage is NOT authrized). III. Diagnses/Indicatins fr which cverage is NOT authrized: A. Nn-FDA apprved indicatins, which are nt addressed in this plicy, unless there is sufficient dcumentatin f efficacy and safety accrding t the ff-label use plicy ERX.PA.01 r evidence f cverage dcuments. IV. Appendices/General Infrmatin Appendix A: Abbreviatin/Acrnym Key DRBA: dpamine receptr blcking agent FDA: Fd and Drug Administratin MAOI: mnamine xidase inhibitr VMAT: vesicular mnamine transprter Appendix B: Therapeutic Alternatives This table prvides a listing f preferred alternative therapy recmmended in the apprval criteria. The drugs listed here may nt be a frmulary agent and may require prir authrizatin. Drug Dsing Regimen Dse Limit/ Maximum Dse tetrabenazine (Xenazine ) Huntingtn s Chrea 12.5 mg PO QD fr 1 week, then 12.5 mg BID, then titrated by 12.5 mg weekly t a tlerated dse up t maximum f 50 mg/day (100 mg/day fr CYP2D6 intermediate r extensive metablizers) 25 mg/dse and 50 mg/day (37.5 mg/dse and 100 mg/day fr CYP2D6 intermediate r extensive metablizers) Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name nly and generic (Brand name ) when the drug is available by bth brand and generic. Appendix C: General Infrmatin Austed is cntraindicated in patients: With Huntingtn s disease wh are suicidal, r have untreated r inadequately treated depressin; Taking reserpine. At least 20 days shuld elapse after stpping reserpine befre starting Austed; Taking mnamine xidase inhibitrs (MAOIs). Austed shuld nt be used in cmbinatin with an MAOI, r within 14 days f discntinuing therapy with an MAOI; Taking tetrabenazine r valbenazine Medicatin-induced mvement disrders, including tardive dyskinesia, are rganized in the DSM V as fllws: neurleptic-induced parkinsnism/ther medicatin-induced parkinsnism, neurleptic malignant syndrme, medicatin-induced acute dystnia, medicatin-induced acute akathisia, tardive dyskinesia, tardive dystnia/tardive akathisia, medicatin-induced pstural tremr, ther medicatin-induced mvement disrder, antidepressant discntinuatin syndrme, and ther adverse effects f medicatin. 5 Tardive dyskinesia is a type f mvement disrder that ccurs secndary t therapy with centrally acting DRBAs (see Appendix C). 5 Typical therapeutic drug classes cntaining DRBAs include first- and secnd-generatin antipsychtics, antiemetics, and tri-cyclic antidepressants (see Appendix D). 5 Other therapeutic drug classes cntaining agents that have been variusly assciated with mvement disrders are listed belw: 6-8 Antiarrhythmics Antiepileptics Antibitics Antihistamines Antichlinergics Antimanics Antidepressants Brnchdilatrs Page 2 f 5

3 Calcium channel blckers Central nervus system stimulants Dpamine agnists Dpamine depleting agents Dpaminergics Gluccrticids Immunsuppressants Md stabilizers Muscle relaxants Oral cntraceptives Appendix D: DSM-V Definitin f Tardive Dyskinesia 5 Tardive Dyskinesia (ICD /ICD-10 G24.01) Invluntary athetid r chreifrm mvements (lasting at least a few weeks) generally f the tngue, lwer face and jaw, and extremities (but smetimes invlving the pharyngeal, diaphragmatic, r trunk muscles) develping in assciatin with the use f a neurleptic medicatin fr at least a few mnths. Symptms may develp after a shrter perid f medicatin use in lder persns. In sme patients, mvements f this type may appear after discntinuatin, r after change r reductin in dsage, f neurleptic medicatins, in which case the cnditin is called neurleptic withdrawal emergent dyskinesia. Because withdrawal emergent dyskinesia is usually time limited, lasting less than 4-8 weeks, dyskinesia that persists beynd this windw is cnsidered t be tardive dyskinesia. Appendix E: Centrally Acting Dpamine Receptr Blcking Agents (Neurleptics) 5,6,9,10 Pharmaclgic Class Therapeutic Class First-generatin Antiemetic agents (typical) antipsychtics Phenthiazine Chlrprmazine Fluphenazine Perphenazine Thiridazine Thithixene Trifluperazine Chlrprmazine Perphenazine Prchlrperazine Prmethazine* Thiethylperazine Butryphenne Halperidl Drperidl Halperidl** Substituted benzamide Dibenzazepine Diphenylbutylpiperidine Quinlne Dibenzazepine Piperazine Dibenzdiazephine Benzisxazle Benzisthiazle Thienbenzdiazepine Pyrimidinne *First generatin H1 antagnist **Off-label use A dibenzxapine that shares prperties with phenthiazines Metclprmide Trimethbenzamide Tri-cyclic antidepressants Amxapine Lxapine Pimzide Secnd-generatin (atypical) antipsychtics Aripiprazle, brexpiprazle Asenapine Cariprazine Clzapine, quetiapine Ilperidne Lurasidne, ziprasidne Olanzapine Paliperidne, risperidne V. Dsage and Administratin Indicatin Dsing Regimen Maximum Dse Huntingtn s chrea 6 mg/day (6 mg nce daily) PO; may be increased weekly by increments f 6 mg/day t a maximum f 48 mg/day 48 mg/day (18 mg/dse and 36 mg/day in pr CYP2D6 metablizers) Page 3 f 5

4 Indicatin Dsing Regimen Maximum Dse Tardive dyskinesia VI. Prduct Availability Tablets: 6 mg, 9 mg, 12 mg 12 mg/day (6 mg twice daily) PO; may be increased weekly by increments f 6 mg/day t a maximum f 48 mg/day 48 mg/day (18 mg/dse and 36 mg/day in pr CYP2D6 metablizers) VII. References 1. Austed Prescribing Infrmatin. Nrth Wales, PA. Teva Pharmaceuticals USA, Inc; August Available at: Accessed February 5, Frank S, et al. Effect f deutetrabenazine n chrea amng patients with Huntingtn disease. JAMA. 2016; 316(1): O Classen D, et al. Indirect tlerability cmparisn f deutetrabenazine and tetrabenazine fr Huntingtn disease. J Clin Mv Disrd. 2017; 4(3): Bhidayasiri R, Fahn S, Weiner WJ, et al. Evidence-based guideline: Treatment f tardive syndrmes. Reprt f the Guideline Develpment Subcmmittee f the American Academy f Neurlgy. Neurlgy. 2013; 31: Medicatin-induced mvement disrders and ther adverse effects f medicatin. Diagnstic and statistical manual f mental disrders, 5th Ed. American Psychiatric Assciatin. 6. Waln O, Jankvic J. An update n tardive dyskinesia: Frm phenmenlgy t treatment. Tremr Other Hyperkinet Mv (N Y). July 12, 2013; 3. pii: tre di: /D88P5Z71. Print Meyer TA, Belsn TE, McAllister R. Tardive dyskinesia: A distressing drug-induced mvement disrder. US Pharm. 2014; 39(1): HS13-HS Lerner PP, Midwnik C, Lerner V. Tardive dyskinesia (syndrme): Current cncept and mdern appraches t its management. Psychiatry Clin Neursci. June 2015; 69(6): Smith HS, Cx LR, Smith BR. Dpamine receptr antagnists. Annals f Palliative Medicine. July 2012; 1(2). DOI: /j.issn Clinical Pharmaclgy [database nline]. Tampa, FL: Gld Standard, Inc.; Available at Accessed February 5, Reviews, Revisins, and Apprvals Date P&T Apprval Date Plicy created Tardive dyskinesia: Added criteria and crrespnding appendices Huntingtn s chrea: Added age requirement per prescribing infrmatin. Added preferencing fr tetrabenazine as it is available generically. Bth indicatins: Added requirement fr n cncmitant use f xenazine r valbenazine fr bth initial and re-auth requests. 2Q 2018 annual review: n significant changes; references reviewed and updated Imprtant Reminder This clinical plicy has been develped by apprpriately experienced and licensed health care prfessinals based n a review and cnsideratin f currently available generally accepted standards f medical practice; peer-reviewed medical literature; gvernment agency/prgram apprval status; evidence-based guidelines and psitins f leading natinal health prfessinal rganizatins; views f physicians practicing in relevant clinical areas affected by this clinical plicy; and ther available clinical infrmatin. This Clinical Plicy is nt intended t dictate t prviders hw t practice medicine, nr des it cnstitute a cntract r guarantee regarding payment r results. Prviders are expected t exercise prfessinal Page 4 f 5

5 medical judgment in prviding the mst apprpriate care, and are slely respnsible fr the medical advice and treatment f members. This plicy is the prperty f Envlve Pharmacy Slutins. Unauthrized cpying, use, and distributin f this Plicy r any infrmatin cntained herein is strictly prhibited. By accessing this plicy, yu agree t be bund by the freging terms and cnditins, in additin t the Site Use Agreement fr Health Plans assciated with Envlve Pharmacy Slutins Envlve Pharmacy Slutins. All rights reserved. All materials are exclusively wned by Envlve Pharmacy Slutins and are prtected by United States cpyright law and internatinal cpyright law. N part f this publicatin may be reprduced, cpied, mdified, distributed, displayed, stred in a retrieval system, transmitted in any frm r by any means, r therwise published withut the prir written permissin f Envlve Pharmacy Slutins. Yu may nt alter r remve any trademark, cpyright r ther ntice cntained herein. Page 5 f 5